COMPARATIVE TRIAL OF DICLOFENAC SUPPOSITORY, PARACETAMOL INFUSION AND THEIR COMBINATION FOR POST CAESAREAN DELIVERY ANALGESIA

Abstract

TITLE: COMPARATIVE TRIAL OF DICLOFENAC SUPPOSITORY, PARACETAMOL INFUSION AND THEIR COMBINATION FOR POST CAESAREAN DELIVERY ANALGESIA INTRODUCTION Pain is unpleasant, emotional and sensory experience. One of the most important aspect of post operative care is pain management. Non-steroidal anti-inflammatory drugs (NSAIDS) have recently gained more popularity in postoperative pain management.Though post-operative pain is better achieved with higher modalities like epidural analgesia but lack of availability of high skilled personnel in peripheral areas of developing countries like India and moreover as they are expensive. Diclofenac suppository and paracetamol infusion are more economical and easily available so these drugs are used to conduct this study. There are very few studies available in literature comparing the postoperative analgesic effect of i.v paracetamol, diclofenac suppository or in combination. Therefore, the aim of present study is to compare the effects of diclofenac suppository, paracetamol infusion and their combination in post caesarean delivery analgesia. By doing this comparative study which helps in finding out efficient analgesic drug and better mode of administration of drugs individually or in combination we can implement for achieving better post operative analgesia. AIMS AND OBJECTIVES  To determine the analgesic efficacy by visual analogue scale pain scores and safety of i.v paracetamol. xii  To determine analgesic efficacy and safety of diclofenac suppository.  To compare analgesic efficacy and safety of individual use of i.v paracetamol and diclofenac suppository and in combination. MATERIALS AND METHODS: This prospective and comparative study conducted from Oct 2018 to June 2020 at Department of Obstetrics and gynecology on the patients admitted in R.L.Jalappa Hospital attached to Sri Devraj Urs Academy of Higher Education and Research,Tamaka, Kolar. A proforma containing detailed information of each patient was designed according to the study protocol. Ethical clearance obtained from the Institutional Ethics Committee. Written and informed consent obtained from patients . A total of 90 women underwent caesarean section have been recruited for the study and were randomly allocated using lottery method into three groups. Three groups, each group comprises of 30 participants. The patients underwent lower segment caesarean section under spinal anaesthesia with the same technique and medicine, (Bupivacaine % 0.5) without receiving any sedation, using No. 27 spinal needle in sitting position at L3-L4 and L3-L2 space by an anaesthesiologist. Post operatively for analgesia patients in Group A received diclofenac suppository 50mg every 8th hrly,Group B received paracetamol infusion 1000mg every 8 th hrly and Group C received 50mg diclofenac suppository and 500 mg intravenous paracetamol every 8th hrly.Pain severity( VAS score) and duration of analgesia ,frequency of additional analgesia required and any side effects were evaluated at 2,4,6,8,12,24hrs post operatively.Patient satisfaction score was evaluated at 24hrs after caesarean section. xiii RESULTSPatients who underwent caeserean section included in the study were in the mean age group of 24 to 25 years. Mean duration of surgery in each of three groups was 60 minutes. Patients received either intravenous paracetamol or diclofenac suppository or the combination of both the drugs. VAS score indicated mild pain during first 24 hours of post-operative period which was comparable between the groups. There was statistically significant difference in median VAS score for a pair of 1) Group A and Group B at 2hrs, 8hrs and 24hrs with P value < 0.05. 2) Group B and Group C at 2hrs, 4hrs, 6hrs, 8hrs, 12hrs, 24hrs with P value < 0.05. 3) Group A and Group C at 2hrs, 4hrs, 6hrs, 8hrs, 12hrs, 24hrs with P value < 0.05. The major findings of the study are VAS score indicated mild pain during first 24 hours of post-operative period which was comparable between the groups. In the present study, there was reduction of pain indicated by VAS score however this reduction was significant in patients receiving paracetamol and diclofenac suppository combination group. Present study reported that combination group was superior to both individual paracetamol infusion group and diclofenac suppository group in post caesarean analgesia. We have observed that pain relief by individual use of paracetamol infusion and diclofenac suppository was similar. The satisfaction score was categorized as excellent by 80% patients in combination group. In Diclofenac group 30% and in Paracetamol group 16.6% categorised as excellent patient satisfaction score. This study indicates a significant effect of concomitant use of intravenous acetaminophen and diclofenac suppository on pain severity reduction and prolonging the postoperative analgesia. xiv In present study the adverse effects such as nausea and epigastric discomfort was higher with diclofenac suppository group 10% followed by Paracetamol group (6.6% side effects) and minimal with combination group(3.3%) CONCLUSION: Paracetamol infusion is as effective as diclofenac suppository in reducing post-operative pain following caesarean section. Diclofenac suppository and i.v paracetamol combination provides more effective postoperative analgesia compared with individual usage of i.v paracetamol or Diclofenac suppository in patients following caesarean section.The combined use of paracetmol and diclofenac suppository has less side effects compared with individual use of either i.v paracetamol or diclofenac suppository